Blue Water Biotech, Inc. (“Blue Water” or the “Company”), a
biotechnology and pharmaceutical company spanning multiple sectors,
today announced the signing of an agreement with Copay Consultants,
LLC (“Copay Consultants”) to build copay assistance programs for
Blue Water’s commercial products, including ENTADFI®, which was
acquired in April and ZONTIVITY®, which is expected to be acquired
in the coming weeks after the signing of an asset purchase
agreement in June.
Copay Consultants team has over 40 years of combined experience
in the life science industry, including creation of manufacturer
sponsored patient savings programs, pharmacy adjudicated copay
discount programs, direct to patient rebates, patient web
enrollment and attestation services, patient messaging, among
others. In this new effort, Blue Water’s commercial team will work
closely with Copay Consultants to design and implement a copay
assistance program for eligible ENTADFI® and ZONTIVITY®
patients.
“Oftentimes, getting a prescription and securing insurance
coverage is only the first step in the process of a patient
initiating therapy,” said Joseph Hernandez, Chairman and Chief
Executive Officer of Blue Water. “When patients arrive at the
pharmacy and are exposed to high out of pocket costs, copay
assistance programs like these can prove critical to ensuring those
patients begin treatment. With our copay programs and through this
collaboration with Copay Consultants, we are excited to show our
commitment to patients across the country and their ability to
afford our treatments.”
After the acquisition of ENTADFI® in April and signing of an
asset purchase agreement to acquire ZONTIVITY® in June, Blue Water
management presented its commercial launch strategy in a letter to
shareholders last month. Recent execution includes significant
progress with Blue Water collaborators and vendors across sales,
marketing, advertising, telehealth development, market access, and
sample distribution. This new agreement with Copay Consultants is
expected to help eligible patients lower the out of pocket costs
associated with treatment and is another critical step towards the
official launch of these products, expected in the coming
months.
About ENTADFI®
ENTADFI® is an oral, once daily treatment for BPH that combines
finasteride, a 5α-reductase inhibitor, and tadalafil, a
phosphodiesterase 5 (PDE5) inhibitor, offering a more effective
treatment option compared to other available therapies. Clinical
trials have shown that ENTADFI® is more effective in treating BPH
symptoms, including urinary frequency, urgency, weak stream, and
difficulty initiating or maintaining urination, compared to
finasteride monotherapy. Additionally, ENTADFI® has demonstrated a
favorable safety profile, with fewer adverse sexual side effects
compared to finasteride. ENTADFI® reduces potential for adverse
sexual side effects, making it a preferred choice for men seeking
relief from BPH symptoms without compromising their sexual health.
ENTADFI® has received FDA approval for the indication of initiating
treatment of the signs and symptoms of BPH in men with an enlarged
prostate for up to 26 weeks. More information about BPH and full
ENTADFI® prescribing information can be found on the product
website at https://entadfipatient.com/.
About
ZONTIVITY®
ZONTIVITY® is a once daily, oral treatment
indicated for the reduction of thrombotic cardiovascular events for
patients with a history of myocardial infarction (MI) or with
peripheral arterial disease (PAD). ZONTIVITY® has been shown to
reduce the rate of a combined endpoint of cardiovascular death, MI,
stroke, and urgent coronary revascularization when used with
aspirin and/or clopidogrel. More information about MI, PAD, and
full ZONTIVITY® prescribing information can be found on the product
website at https://zontivity.com/.
About Copay Consultants
Copay Consultants, LLC is a service provider in the marketing
and patient access space within the life science industry. Working
as an extension of marketing and market access teams, Copay
Consultants develops manufacture sponsored savings programs catered
to individual products, market trends and competitive landscape
which provide affordable access for patients. For more information
about Copay Consultants, visit www.copayconsultants.com
About Blue Water Biotech
Blue Water Biotech, Inc. is a biotechnology and
pharmaceutical company focused on developing and commercializing
transformational therapies to address significant health challenges
globally. Headquartered in Cincinnati, OH, the Company owns
ENTADFI®, an FDA-approved, once daily pill that combines
finasteride and tadalafil for the treatment of benign prostatic
hyperplasia. This combination allows men to receive treatment for
their symptoms of benign prostatic hyperplasia without the negative
sexual side effects typically seen in patients on finasteride
alone. The Company is also in the process of acquiring the approved
therapies from WraSer, LLC, and Xspire Pharma, LLC, including
ZONTIVITY® (reduction of thrombotic cardiovascular events in
patients with myocardial infarction or with peripheral arterial
disease), OTOVEL® (acute otitis media with tympanostomy tubes),
CETRAXAL® (acute otitis externa), CONJUPRI® (hypertension), TREZIX™
(moderate to severe pain) and NALFON® (NSAID treatment for pain and
inflammation). The Company also has a robust preclinical vaccine
pipeline. Blue Water holds the rights to proprietary technology
developed at the University of Oxford, Cincinnati Children’s
Hospital Medical Center, St. Jude Children’s Hospital, and The
University of Texas Health Science Center at San Antonio. Blue
Water is developing a Streptococcus pneumoniae vaccine candidate,
designed to specifically prevent highly infectious middle ear
infections, known as AOM, in children, and prevention of pneumonia
in the elderly. The Company is also developing a universal flu
vaccine that will provide protection from all virulent strains in
addition to licensing a novel norovirus S&P nanoparticle
versatile virus-like particle vaccine platform from Cincinnati
Children’s to develop vaccines for multiple infectious diseases,
including Marburg and monkeypox, among others. Additionally, the
Company is developing a Chlamydia vaccine candidate with UT Health
Science Center San Antonio to prevent infection and reduce the need
for antibiotic treatment associated with contracting Chlamydia
disease. For more information about Blue Water, visit
www.bwbioinc.com.
Forward-Looking Statements
Certain statements in this press release are
forward-looking within the meaning of the Private Securities
Litigation Reform Act of 1995. These statements may be identified
by the use of forward-looking words such as “anticipate,”
“believe,” “forecast,” “estimate,” “expect,” and “intend,” among
others. These forward-looking statements (including, without
limitation, the anticipated benefits of the Company’s agreement
with Copay Consultants) are based on Blue Water’s current
expectations and actual results could differ materially. There are
a number of factors that could cause actual events to differ
materially from those indicated by such forward-looking statements.
These factors include, but are not limited to, market and other
conditions, risks related to Blue Water’s ability to realize the
benefits of its acquisitions of
ENTADFI®, ZONTIVITY®,
OTOVEL®, CETRAXAL®, CONJUPRI®,
TREZIX™ and NALFON®; risks related to
Blue Water’s ability to expand its business scope, commercialize
ENTADFI® and integrate the assets and commercial operations
being acquired from WraSer, LLC, and Xspire Pharma, LLC into Blue
Water’s business; risks related to Blue Water’s ability to attract,
hire and retain skilled personnel and establish an effective sales
team; risks related to Blue Water’s ability to establish, maintain
and optimize key third party commercial collaboration agreements
(such as those with Knipper, UpScript, IQVIA, APS and bfw); risks
related to the Company’s present need for capital to close its
asset acquisitions, commercially launch the Company’s acquired
products and have adequate working capital; risks related to the
development of Blue Water’s vaccine candidates; the failure to
obtain FDA clearances or approvals and noncompliance with FDA
regulations; risks related to the timing and progress of clinical
development of our product candidates; uncertainties of patent
protection and litigation; uncertainties of government or third
party payor reimbursement; limited research and development efforts
and dependence upon third parties; and substantial competition. As
with any commercial-stage pharmaceutical product or any product
candidate under clinical development, there are significant risks
in the development, regulatory approval and commercialization of
pharmaceutical products. Blue Water does not undertake an
obligation to update or revise any forward-looking statement.
Investors should read the risk factors set forth in Blue Water’s
Annual Report on Form 10-K, filed with the SEC on March 9, 2023 and
periodic reports filed with the SEC on or after the date thereof.
All of Blue Water’s forward-looking statements are expressly
qualified by all such risk factors and other cautionary statements.
The information set forth herein speaks only as of the date
thereof.
Media Contact Information:Blue Water Media
RelationsTelephone: (646) 942-5591 Email:
Nic.Johnson@russopartnersllc.com
Investor Contact Information:Blue Water Investor RelationsEmail:
investors@bwbioinc.com
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